SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy (NCT07251881) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy
86 participantsStarted 2026-05
Plain-language summary
During certain heart surgeries, the sternum is opened and must then be closed securely. The study compares two closure methods - steel wires and SuperCable - in terms of stability, healing, and patient satisfaction. This investigation aims to demonstrate that the iso-elastic properties of the SuperCable Sternal Closure System result in faster sternal bone healing, reduced postoperative pain, shorter hospital stay, and improved physical recovery compared to conventional steel wire sternal closure. Eighty-six patients are participating and are randomly assigned to one of the two groups. After the operation, pain, healing, and possible complications are checked. The patients are examined 3 and 6 months after the operation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of Informed Consent: The subject must have signed and dated the informed consent form prior to any study-related procedures.
* Willingness and Ability to Comply: The subject must express a stated willingness to comply with all study procedures and be available for the duration of the study.
* Age and Sex:
* Age: The subject must be at least 18 years old.
* Sex: Both male and female subjects are eligible. In line with the "Sex and Gender in Research Involving Humans" recommendations, data will be stratified and analyzed by sex to identify any potential differences in outcomes.
* Language Competence: The subject must possess sufficient German language skills to accurately complete the postoperative survey
* Travel Capability: The subject must have the ability to travel for all planned study visits, including scheduled CT scans
* Surgical Procedure: The subject must be scheduled for elective coronary artery bypass graft (CABG) procedures, as this is the focus of the investigation
* Adherence to Visit Schedule: The subject must be willing to adhere to all scheduled visits and undergo CT scans as outlined in the study protocol
Exclusion Criteria:
* Pharmacological Restrictions: Current use of corticosteroids or any immunosuppressive medication
* Prior Treatments and Therapies: History of radiation therapy to the thorax
* Reproductive Considerations:
* Pregnancy, or the intent to become pregnant during the study period
* Lactation or cur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sternal bone healing
Timeframe: day5, day90, day180 (might be waived depending on outcome on day90)